An AHU plays a critical role in maintaining cleanroom conditions, controlling particulate contamination, and ensuring compliance with regulatory requirements (USFDA, EU GMP) 1. Air Intake and Pre-Filtration Fresh air Intake: The AHU draws in fresh air and passes it through pre-filters (10-micron filters) ...

User Requirement Specificatio (URS): Define the intended use of the instrument. List performance requirements, such as accuracy, precision, and operational range. Include compliance needs with GMP, GDP, or other regulatory guidelines. Design Qualification (DQ): Document that the design of the instrument ...

Air changes per hour (ACPH) Ref. Guideline: ISO 14644 Air changes in pharmaceutical cleanrooms play a significant role in maintaining the cleanroom quality as per ISO Cleanroom Classification through the HVAC system. Air change per hour is the number of total replacements of any room air in one hour. ...

In the pharmaceutical industry, the selection of flooring is critical to ensure compliance with regulatory standards like GMP and ISO 14644. Floors in cleanrooms, laboratories, and production areas must be durable, easy to clean, and resistant to chemical exposure. Epoxy Flooring Epoxy flooring is ...

API refers to the key ingredient or chemical that makes the drug work. While a finished formulation or a formulation intermediate is the process in which different chemicals including the active ingredients are mixed in specific ratios to produce a specific drug. API (Active Pharmaceutical Ingredient): The ...

Polyurethane is a versatile material that plays a significant role in the pharmaceutical industry, particularly in cleanroom environments, where stringent cleanliness and durability standards are required. Trolley Wheels: Used in cleanroom trolleys to transport materials safely without contaminating ...

In pharmaceutical cleanrooms, a cross-over bench serves as a physical and procedural barrier between different cleanliness zones, such as “unclean” (gray areas) and “clean” areas. Prevent Contamination: Ensures that particles, microorganisms, or dirt from street footwear or garments ...

1.0 OBJECTIVE: To lay down a procedure for Operation and Cleaning of Lift. 2.0 SCOPE: This Procedure is Applicable to Operation & Cleaning of Lift (Make: Omega) in Administration Block used for Man Movement at ……… 3.0 RESPONSIBILITY: Officer / Executive Personnel & Administration / HR 4.0 ...

1.0 OBJECTIVE: To lay down a Procedure for Palm Scanning for Employees. 2.0 SCOPE: This SOP is applicable for attendance by Palm Punching of Company Employees (All Male/ Female Staff / Workers) during Entry and Exit at ……………. 3.0 RESPONSIBILITY: All Employees 4.0 ACCOUNTABILITY: Head HR 5.0 ...

1.0 OBJECTIVE: To lay down a procedure for Preparation of Signature Log of Authorized Signatory. 2.0 SCOPE: This Procedure is applicable to define the procedure for Preparation of Signature Log of Authorized Personnel at ……………….. 3.0 RESPONSIBILITY: Officer / Executive Personnel & Administration ...